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Adolescent and Young Adult Cancer SurvivorsNCT03016728

Physical Activity for Adolescent and Young Adult Cancer Survivors

A study testing Physical Activity in people with Adolescent and Young Adult Cancer Survivors, run by University of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. Read more about this study

Who is it for?
Ages 15 to 44 years
What is being tested?
Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteCanada
Study dates
11 Sep 2017to 5 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 44 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Have been diagnosed with cancer for the first time between the ages of 15 and 39 years;
  • Have completed cancer treatment within 5 years;
  • Currently between the ages of 15 to 44 years;
  • Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells that have spread from the primary cancer), or second cancers (i.e., a new different cancer);
  • Live within 100 km of the University of Ottawa;
  • Be inactive or insufficiently active as determined by a single item screening question (i.e., participants must respond "no" to the following question: are you currently engaging in moderate physical activity, defined as activity that increases your heart rate and causes you to sweat, on 3 or more days a week?). Screening participants based on their level of physical activity will ensure only those individuals for whom the intervention will have the largest effect are recruited;
  • Able to read, understand, and provide informed consent in English;
  • Ready for physical activity as indicated by answering Physical Activity Readiness Questions (PAR-Q). If participants are not ready for physical activity as determined by the PAR-Q they will need to complete a Physical Activity Readiness Medical Examination Form.

Who cannot join

  • Physical impairments precluding participation in physical activity;
  • Unwilling or unable to sign the Participant Informed Consent Form;
  • Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest.
  • Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria.
  • ADDITIONAL INCLUSION CRITERIA:
  • Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks;
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  • Able to read, understand, and provide informed consent in English for the additional assessments.
  • ADDITIONAL EXCLUSION CRITERIA:
  • Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
  • Claustrophobia;
  • Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
  • Lower back pain that would preclude a person from lying relatively still for one hour;
  • Substance use disorder as assessed by a single item question (i.e., participants must respond "no" to the following question: Have you been told, in the last five years, by your healthcare provider that you have a substance use disorder?).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

Other trials in Canada

About this study

Official title: Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention

More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.

Being tested
Physical Activity
Keywords
exercise, physical activity, pilot study, randomized controlled trial, cancer, adolescent and young adult, AYA
Medical subject headings
Motor Activity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.

Study groups in NCT03016728
Study groupRoleWhat they receive
Physical ActivityExperimentalParticipants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.
Receives: Behavioral: Physical Activity
Wait-List ControlNo interventionParticipants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rates

    The number of eligible participants who enrol in the study out of the number who are referred.

    Measured: Through study completion, an average of 12-24 weeks

  2. Retention Rates

    The number of participants completing the intervention and all scheduled assessments.

    Measured: Through study completion, an average of 12-24 weeks

  3. Adherence Rates

    The number of physical activity sessions engaged in out of the total recommended as part of the intervention.

    Measured: Through study completion, an average of 12-24 weeks

  4. Number of Participants with Adverse Events

    The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.

    Measured: Through study completion, an average of 12-24 weeks

Secondary outcomes (16)

  1. Physical Activity Behaviour: Daily Physical Activity Logbook

    Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).

    Measured: Through study completion, an average of 12-24 weeks

  2. Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)

    Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)

  3. Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)

    Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)

  4. Resting Heart Rate

    Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  5. Blood Pressure

    Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  6. Body Composition: Body Mass Index

    Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  7. Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)

    Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  8. Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)

    Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  9. Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)

    Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  10. Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)

    Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  11. Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, & Jackson, 2010)

    Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  12. Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)

    Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  13. Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)

    Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  14. Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)

    Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  15. Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)

    Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.

    Measured: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)

  16. Participants Experiences: Qualitative Interviews

    Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.

    Measured: Baseline (week 0), post-intervention (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start11 Sep 2017
  3. Primary completion16 Apr 2019
  4. Study completion5 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016728
Sponsor's protocol ID
Ottawa
Status last verified
May 2019
First submitted
24 Dec 2016
Last updated
31 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PubMed 4053261

  • Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.

  • Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.

  • Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.

  • McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757.

    PubMed 8433355

  • Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438.

    PubMed 20733208

  • Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.

  • Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.

  • Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.

    PubMed 8827649

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PubMed 1593914

  • Wurz A, Ayson G, Smith AM, Brunet J. A proof-of-concept sub-study exploring feasibility and preliminary evidence for the role of physical activity on neural activity during executive functioning tasks among young adults after cancer treatment. BMC Neurol. 2021 Aug 4;21(1):300. doi: 10.1186/s12883-021-02280-y.

    PubMed 34344355

  • Wurz A, Price J, Brunet J. Understanding adolescents' and young adults' self-perceptions after cancer treatment in the context of a two-arm, mixed-methods pilot randomized controlled physical activity trial. Support Care Cancer. 2021 Aug;29(8):4439-4450. doi: 10.1007/s00520-020-05974-0. Epub 2021 Jan 15.

    PubMed 33449169

  • Wurz A, Brunet J. Exploring the feasibility and acceptability of a mixed-methods pilot randomized controlled trial testing a 12-week physical activity intervention with adolescent and young adult cancer survivors. Pilot Feasibility Stud. 2019 Dec 20;5:154. doi: 10.1186/s40814-019-0530-6. eCollection 2019.

    PubMed 31890266

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity in people with Adolescent and Young Adult Cancer Survivors, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rates (time frame: Through study completion, an average of 12-24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016728, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.

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